recombinant human p53 adenovirus injection

Recombinant human p53 adenovirus injection, widely known by the brand name Gendicine, is a pioneering gene therapy developed by Shenzhen SiBiono GeneTech. It holds the distinction of being the first gene therapy product to receive regulatory approval for clinical use, granted by China's State Food and Drug Administration (SFDA) in 2003. The therapy utilizes a recombinant, replication-deficient serotype 5 adenovirus (Ad5) vector to deliver the wild-type human TP53 tumor suppressor gene into cancer cells. Administered primarily via intratumoral injection, it is indicated for the treatment of various solid tumors, most notably head and neck squamous cell carcinoma (HNSCC), including nasopharyngeal carcinoma. By restoring the functional p53 protein, the drug triggers cell cycle arrest and apoptosis in tumor cells that harbor TP53 mutations or deletions, and it is frequently used in combination with radiotherapy or chemotherapy to enhance therapeutic outcomes.

Brand names

GendicineJin Di Xin

Other names

recombinant human p53 adenovirus injectionAd-p53Ad-p-53Ad-p 53adenoviral p53